Multivessel Pulmonary Vein Stenosis Clinical Trial
Official title:
Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Multivessel Pulmonary Vein Stenosis
Prospective, single center, descriptive study in 14 infants/children with multivessel
pulmonary vein stenosis stratified for patients with or without underlying cardiac disease.
Group 1: Patients without additional structural heart disease and multivessel pulmonary vein
stenosis.
Group 2: Patients with additional structural heart disease and multivessel pulmonary vein
stenosis.
Patients identified at the time of presentation to their cardiologist will be asked to
provide a urine sample for analysis. If blood is being drawn for other clinical tests, an
extra vial of blood will be collected for measurement of bFGF, VEGF, angiopoietin 1&2 and
ephrin. At the time of blood draws, approximately 4 cc's of heparin blood will be obtained
and processed as detailed below. Blood and/or urine samples will be coordinated through the
data manager and will be performed only when blood is being obtained for other reasons.
Initially, blood samples will be sent to Lab Control, spun down, and the plasma isolated.
Plasma will be coded, then frozen at -200C in the research lab. Urine samples will be
aliquoted into vials and stored at -20 until further analysis.
All patient information will be kept confidential. Individual results will not be provided
to patients. Identifiers to patient information will be maintained. No identifying patient
information will be used in publications that might result from these studies. Information
to be collected by the data manager will include age, sex, date of diagnosis and
interventions.
The specific aim is to assess angiogenic growth factor concentrations in urine and blood
from patients with both congenital and acquired multivessel pulmonary vein stenosis.
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Observational Model: Cohort, Time Perspective: Prospective